Diarrhea Predominant Irritable Bowel SyndromePhase 2NCT01896583
A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study testing ASP7147 in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Seldar Pharma, Inc. at 13 sites in United States.
Trial summary
This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diarrhea Predominant Irritable Bowel Syndrome
- What is being tested?
- ASP7147
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 13 sitesUnited States
- Study dates
- Nov 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent
- Men or women aged 18-75 years
- Patient has IBS with diarrhea (IBS-D)
- Ability to communicate with the investigator
Who cannot join
- IBS with constipation (IBS-C) or mixed IBS (IBS-M)
- Other significant disease or condition that may interfere with trial completion
- Untreated lactose intolerance
- History of alcohol or drug abuse in past two years
- Participation in other clinical trials within prior month
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Remington-Davis, Inc.
Columbus, Ohio, 43215
Shahram Jacobs, M.D., Inc.
Encino, California, 91436
Grossmont Center for Clinical Research
La Mesa, California, 91942
OM Medical
Las Vegas, Nevada, 89119
San Marcus Research Clinic Inc
Miami, Florida, 33015
Suncoast Research Group, LLC
Miami, Florida, 33135
Elite Clinical Studies
Phoenix, Arizona, 85018
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78288
Probe Clinical Research Group
Santa Ana, California, 92701
Sundance Clinical Research
St Louis, Missouri, 63141
Meridien Research
St. Petersburg, Florida, 33709
MedVadis Research Corporation
Watertown, Massachusetts, 02472
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety and Tolerability, of ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.
- Being tested
- ASP7147, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP7147Drug
300 mg, tablet, twice per day for 4 weeks oral
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ASP7147 | Experimental | ASP7147, 300 mg, tablet, twice per day for 4 weeks oral Receives: Drug: ASP7147 |
| Placebo | Placebo comparator | oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain
10-point pain scale
Measured: 4 weeks
Secondary outcomes (2)
Stool consistency
Bristol Stool Scale (7-point scale)
Measured: 4 weeks
Stool frequency
Number of bowel movements per day
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seldar Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896583
- Sponsor's protocol ID
- 7147-CL-0003
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2013
- Last updated
- 6 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety and Tolerability, of ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT01896583
- Acronym / sponsor ID
- 7147-CL-0003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seldar Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP7147 | Experimental | Drug: ASP7147ASP7147, 300 mg, tablet, twice per day for 4 weeks oral |
| Placebo | Placebo comparator | Drug: Placebooral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent
- Men or women aged 18-75 years
- Patient has IBS with diarrhea (IBS-D)
- Ability to communicate with the investigator
Key exclusion criteria (5 listed)
- IBS with constipation (IBS-C) or mixed IBS (IBS-M)
- Other significant disease or condition that may interfere with trial completion
- Untreated lactose intolerance
- History of alcohol or drug abuse in past two years
- Participation in other clinical trials within prior month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP7147300 mg, tablet, twice per day for 4 weeks oral | Drug | ASP7147 |
| Placebo | Drug | Placebo |
Primary outcome
Abdominal pain
Time frame: 4 weeks
10-point pain scale
2 secondary outcomes
Stool consistency
Time frame: 4 weeks
Stool frequency
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP7147 in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Seldar Pharma, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.